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SOP Guide for Pharma

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Revised SOPs for Ointments V 2.0

Ointments: SOP for Cleaning and Re-Starting Manufacturing Lines – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define a structured method for cleaning and re-starting manufacturing lines after batch completion or process interruptions, ensuring compliance with GMP standards.
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Ointments V 2.0

Ointments: SOP for Handling Interruptions During Ointment Manufacturing – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define a structured approach for handling interruptions during ointment manufacturing to minimize product loss, maintain compliance with GMP standards, and ensure process integrity.
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Ointments V 2.0

Ointments: SOP for Monitoring Real-Time Process Parameters – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for monitoring real-time process parameters during the manufacturing of ointments to ensure process consistency, product quality, and regulatory compliance.
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Ointments V 2.0

Ointments: SOP for Adjusting Batch Sizes According to Production Needs – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for adjusting batch sizes in ointment production to align with market demand, production efficiency, and resource availability while ensuring compliance with GMP regulations.
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Ointments V 2.0

Ointments: SOP for Preventing Air Entrapment During Mixing – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define a systematic process for preventing air entrapment during the mixing of ointments. Air entrapment can lead to product instability, batch inconsistency, and reduced efficacy of the final formulation.
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Ointments V 2.0

Ointments: SOP for Ensuring Proper Dispersion of Active Ingredients – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define the process for ensuring the proper dispersion of active ingredients in ointment formulations. Proper dispersion is crucial to maintaining uniformity, product stability, and therapeutic effectiveness.
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Ointments V 2.0

Ointments: SOP for Incorporating Temperature-Sensitive Ingredients – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define the process for incorporating temperature-sensitive ingredients into ointment formulations. These ingredients require strict temperature control to prevent degradation, maintain potency, and ensure product stability.
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Ointments V 2.0

Ointments: SOP for Adding Viscosity Modifiers in the Mixing Process – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to define a systematic approach for adding viscosity modifiers in the mixing process of pharmaceutical ointments. Proper incorporation of viscosity modifiers ensures batch uniformity, stability, and optimal spreadability of the final product.
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Ointments V 2.0

Ointments: SOP for Preventing Foaming During Manufacturing – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach to preventing excessive foaming during the manufacturing of pharmaceutical ointments. Foaming can lead to production inefficiencies, batch inconsistencies, air entrapment, and reduced product stability.
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Ointments V 2.0

Ointments: SOP for Heating Ointment Bases to Target Temperatures – V 2.0

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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for heating ointment bases to target temperatures to ensure optimal consistency, homogeneity, and stability. Proper temperature control is essential for the dissolution of active ingredients, excipients, and emulsifiers.
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Ointments V 2.0

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

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